← Back to catalogue

Cardiovit Ft-1 Cro

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 3.900865Model CARDIOVIT FT-1 CRO

by Schiller Ag

Identity

Trade Name
CARDIOVIT FT-1 CRO EUDAMED
CARDIOVIT® FT-1 FDA UDI
Generic Name
Electrocardiograph, professional, multichannel FDA UDI
Device Name
CARDIOVIT FT-1 CRO EUDAMED
The CARDIOVIT® FT-1 is a 12-lead ECG device used for the recording, analysis and evaluation of ECG recordings. FDA UDI
Model / Reference
CARDIOVIT FT-1 CRO EUDAMED
3.900865 EUDAMEDFDA UDI
Description
The CARDIOVIT® FT-1 is a 12-lead ECG device used for the recording, analysis and evaluation of ECG recordings. FDA UDI

Identifiers

Catalog Number
3.900865 FDA UDI
Primary DI / UDI-DI
07613365003642 EUDAMEDFDA UDI
Basic UDI-DI
761336500000002152 EUDAMED
Direct Marketing DI
07613365003642 EUDAMED
510(k) Number
K170182 FDA UDI
FDA Product Code
DPS FDA UDI
EMDN Code
Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
GMDN Term
Electrocardiograph, professional, multichannel FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
870.2340 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Cardiovit Ft-1 Cro by Schiller AG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Schiller Ag
EUDAMED SRN
CH-MF-000012722
Authorised Representative
SCHILLER Medizintechnik GmbH DE-AR-000006934

Sources (3)

  • EUDAMED a5dcce45-5ef6-476e-8a10-6a7618309535 61 fields · synced Jul 30, 2026
  • FDA UDI 5298c107-9ae8-482d-89a0-4c82283c9e2a 37 fields · synced May 30, 2026
  • FDA 510(k) K170182 1 fields · synced May 18, 2026